Recruiting
Phase 3

NOA VOLUME & JUVÉDERM VOLUMA XC

Sponsor:

AbbVie

Code:

NCT06734351

Conditions

Mid Face Volume Deficit

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

NOA VOLUME

VOLUMA XC

Study Details

Brief summary:

Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).

NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.

Participants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.

Conditions

Mid Face Volume Deficit

Study ID

NCT06734351

Start date

Dec 16, 2024

Status verified date

Jun, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.
  • Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.

Exclusion Criteria:

  • Significant skin laxity in the midface in the opinion of the TI.
  • Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
  • Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.

Study Design

Enrollment

231 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: NOA VOLUME

Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.

experimental: Cohort 1: VOLUMA XC

Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.

experimental: Cohort 2: NOA VOLUME

Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.

experimental: Cohort 2: VOLUMA XC

Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.

Interventions

NOA VOLUME

Injections

VOLUMA XC

Injections

Primary outcome measure

  • Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS) [ Time Frame: Month 6 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Month 31 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Total Skin and Beauty Dermatology Center /ID# 258164

Recruiting

Birmingham, Alabama, United States, 35205

Advanced Research Associates - Glendale /ID# 276812

Recruiting

Glendale, Arizona, United States, 85308

West Dermatology La Jolla /ID# 278590

Recruiting

San Diego, California, United States, 92121

Susan H. Weinkle MD /ID# 258160

Recruiting

Bradenton, Florida, United States, 34209-5642

Hevia Cosmetic Dermatology /ID# 258165

Recruiting

Coral Gables, Florida, United States, 33134

Skin Research Institute LLC /ID# 258158

Recruiting

Coral Gables, Florida, United States, 33146-1837

Atlanta Biomedical Clinical Research /ID# 261210

Recruiting

Atlanta, Georgia, United States, 30331-2160

Contacts

Site Coordinator

678-515-3446

Pure Dermatology /ID# 258168

Recruiting

Metairie, Louisiana, United States, 70001

Aesthetic Center at Woodholme /ID# 258166

Recruiting

Baltimore, Maryland, United States, 21208-6391

Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211

Recruiting

Latham, New York, United States, 12110

Jane Yoo MD /ID# 279811

Recruiting

New York, New York, United States, 10019

Northwest Dermatology Institute /ID# 258167

Recruiting

Portland, Oregon, United States, 97210-2859

Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156

Recruiting

Austin, Texas, United States, 78746-4720

SkinDC /ID# 258163

Recruiting

Arlington, Virginia, United States, 22209

EthiQ2 Research, LLC /ID# 258906

Recruiting

Brookfield, Wisconsin, United States, 53005

More Information

Sponsor

AbbVie

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Mid Face Volume Deficit
  • NOA VOLUME
  • JUVÉDERM® VOLUMA® XC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.